Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

Obstructive Sleep Apnea Clinical Trial

Official title: Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

Status Active, not recruiting

Clinical Trial Summary

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

Clinical Trial Description

GOALS AND EXPECTED OUTCOMES OF THE PROPOSED RESEARCH The purpose of this proposal is to test a novel cognitive-behavioral therapy (CBT) intervention to increase continuous positive airway pressure (CPAP) treatment adherence for PTSD Veterans with a diagnosis of obstructive sleep apnea (OSA). PTSD is a common, debilitating psychiatric consequence of exposure to trauma and a source of significant disability among U.S. war Veterans. The largest epidemiologic study of PTSD in Vietnam Veterans estimates that 15% of Vietnam Veterans suffer from PTSD [3]. The investigators' research on OSA in Vietnam era Veterans found that 69% of the Veterans in the sample had an Apnea-Hypopnea Index (AHI) 10 [4]. OSA is likely present in 50% of middle-aged and older VA patients [4, 5]. The recurrent hypoxemia and sleep fragmentation associated with OSA can lead to neural injury and functional impairment. Efficacious treatments are available for OSA (e.g., CPAP); however, Veterans with OSA frequently fail to use them [4, 6, 7], leaving these Veterans at risk for cognitive dysfunction [8], deterioration of physical health [9], and negative functional outcomes [10]. The investigators' long-term goal is to improve Veterans' functional outcomes by improving adherence to CPAP. If this intervention proves successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

RESEARCH DESIGN AND STRATEGY The reasons for low CPAP adherence include barriers related to discomfort in using CPAP and psychological barriers to behavior change [11]. A CBT treatment to improve CPAP adherence, CBT-OSA, has been successfully applied in civilian randomized controlled trials (RCTs) [12, 13]. The proposed VA intervention would involve delivery of CBT-OSA to PTSD Veterans to foster long-term CPAP adherence. The CBT-OSA treatment would build on the VISN 21 MIRECC's expertise in CBT interventions [e.g., VA rollout of CBT-Insomnia] as well as on the investigators' current research on PTSD Veterans with OSA. In this sample, the vast majority were not diagnosed with OSA prior to study entry; however, 69% of the participants had an AHI 10 [4]. Of the Veterans previously diagnosed with OSA, 63% were not using their CPAP. Thus, CPAP adherence treatment for PTSD Veterans is the next logical step in the investigators' research. Specifically, the investigators propose a 1-year parallel-group RCT involving 120 PTSD Veterans with a diagnosis of OSA. All participants will receive treatment as usual in VA Pulmonary Service. Participants in the active arm will receive CBT-OSA from a trained Clinical Psychologist. The other arm will receive individual Education based treatment, but not CBT-OSA. Participants in both arms will receive weekly, individual sessions during the first 4 weeks of CPAP treatment and 4 booster sessions during the 1-year protocol. These two arms will be referred to hereafter as the CBT-OSA and the Education groups.

*The investigators will add telehealth treatment as an option for participants due to the COVID-19 pandemic. Research visits may be conducted either in-person or via telehealth (e.g., via video or telephone). Telehealth sessions are subject to approval by the research team. Videoconferencing in particular, requires certain features such as hardware, internet accessibility, and telephone capability.

HYPOTHESES Hypothesis 1. (Primary) Effect of CBT on CPAP usage. The investigators hypothesize that the CBT-OSA group will use CPAP more hours per night on average than the Education group. ANCOVA will be used to test group differences over time in hours of "mask-on" CPAP usage per night. [Primary endpoint: mean of Days 335-365.] Hypothesis 2. (Secondary) Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. The investigators hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report more improvement in the ease of performing everyday activities compared to that reported by those in the Education group. ANCOVA will be used to test group differences over time in the total score on the Functional Outcomes of Sleep Questionnaire (FOSQ; [14], at Days 0, 21, 365 (endpoint).

Hypothesis 3. (Secondary) Effect of CBT on Cognitive Outcomes. The investigators hypothesize that the CBT-OSA group will have better cognitive outcomes than the Education group over time. ANCOVA will be applied to the Rey Auditory Verbal Learning Test, Delayed Recall Score with the primary endpoint at Day 365.

Hypothesis 4. (Secondary) Effect of CBT on PTSD. The investigators hypothesize that the CBT-OSA group will have fewer PTSD symptoms than the Education group over time. ANCOVA will be used to test group differences over time in the total score on the PTSD Checklist for DSM-5 (PCL-5), measured at Days 0, 21, 365. Primary endpoint is Day 365.

Exploratory and Supplementary Analyses. (Secondary): Individual Differences in Response (Moderators). Severity of OSA, initial self-efficacy, and other covariates (measured at the pre-treatment Screening Visit) will be examined in exploratory, hypothesis-generating analyses to determine "in whom" CBT-OSA works best. Mechanisms of Action (Mediators). Because CBT-OSA is designed to increase self-efficacy in CPAP adherence, the investigators aim to show that some of the effect of CBT-OSA on CPAP usage is mediated by change in the self-rated Self-Efficacy Measure for Sleep Apnea (SEMSA) [15], measured at Days 0, 21, 365.

HOW THE PROPOSED WORK WILL ADDRESS LONGER-TERM GOALS This research fits the VA's goal to reduce functional disabilities in PTSD Veterans with chronic medical conditions. It is designed to not only determine the benefit of this intervention overall, but also to determine in which Veterans CBT-OSA works best. The dataset collected will enable researchers to troubleshoot the intervention and propose improved interventions. ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Posttraumatic Stress Disorder
• PTSD
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT02641496
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2017
• Completion date: June 30, 2023